Fitbit Tracking for Post-Surgery Ambulation

Recruiting at 1 trial location

Overseen By Anupama Singh, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Non-ambulatory, Cognitive disease, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is examining collecting data on steps walked (ambulation) per day by thoracic surgery patients over the age of 65 years-old before surgery. The name(s) of the study device involved in this study is: * Fitbit inspire

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Fitbit Inspire for post-surgery ambulation?

Research shows that wearable devices like Fitbits can effectively track changes in physical activity and recovery after surgery, providing continuous and individualized data. Although a study found no significant difference in steps with alarms, it demonstrated the potential of activity trackers to quantify ambulation, a key part of recovery. ^{1 2 3 4 5}

Is using a Fitbit for tracking post-surgery activity safe?

Research shows that using Fitbits and similar activity trackers is generally safe for monitoring recovery after surgery. They help track steps, heart rate, and sleep without causing harm, and are used in various surgeries to provide valuable recovery data. ^{1 2 3 4 6}

How does Fitbit tracking differ from other treatments for post-surgery ambulation?

Fitbit tracking is unique because it uses a wearable device to monitor physical activity and recovery in real-time, providing continuous and individualized data on a patient's movement after surgery. Unlike traditional methods that may rely on self-reported activity or periodic assessments, Fitbit offers a more detailed and ongoing picture of a patient's recovery process. ^{1 7 8 9 10}

Research Team

Michael T Jaklitsch, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for people aged 65 or older who are scheduled for major lung surgery at Brigham and Women's Hospital. They must be able to walk and give consent, without urgent cardiac diseases that need testing or surgeries so immediate they can't wait for the study period.

Inclusion Criteria

I am 65 or older and will have chest surgery at Brigham and Women's Hospital.

Exclusion Criteria

My surgery needs to happen sooner than the trial's required timeframe.

I have heart problems that need testing before I can join.

I cannot walk and use a wheelchair for mobility.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Exercise Tracking

Participants use a Fitbit to track daily steps for 1 week prior to surgery. They keep a log of their steps and receive a progress check-in call.

1 week

1 visit (in-person), 1 call (virtual)

Follow-up

Participants return the step-tracker and log either at a pre-surgery clinic visit or on the day of surgery.

1 day

1 visit (in-person)

Treatment Details

Interventions

• Fitbit Inspire

Trial Overview The study is tracking how many steps patients over 65 take each day using a Fitbit Inspire before undergoing thoracic surgery. The goal is to collect data on their physical activity levels prior to the operation.

Participant Groups

Group I: PRE-OPERATIVE EXERCISE TRACKING Experimental Treatment 1 Intervention

Participant baseline information will be collected from their electronic medical records. After enrollment, participants will be provided a mobile device (Fitbit) to wear for tracking steps for 1 week prior to their scheduled surgery. Participants will keep a log of daily steps for the 1 week they are wearing the device and receive one progress check-in call during the week. The device and log will be turned in either on a pre-surgery clinic visit or on the day of surgery whichever comes first.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Findings from Research

A study involving 66-118 patients who underwent weight loss surgery showed that post-operative weeks were linked to decreased daily steps, less time spent walking, and improved sleep metrics, indicating significant lifestyle changes after surgery.

The research highlights the effectiveness of consumer-grade wearable devices, like Fitbits, in monitoring behavioral and physiological changes during recovery, suggesting they could be valuable tools for tracking patient progress in a convenient and continuous manner.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Digital Assessment for Weight Loss Surgery Patients. Ramirez, E., Marinsek, N., Bradshaw, B., et al.[2020]

The study involved 48 patients recovering from elective colorectal procedures, and it aimed to see if activity trackers with alarms would increase their postoperative ambulation.

Despite the use of trackers with alarms, there was no significant increase in daily steps compared to trackers without alarms, indicating that while tracking ambulation is useful, alarms alone may not enhance postoperative activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Activity Trackers With vs. Without Alarms to Increase Postoperative Ambulation: A Randomized Control Trial. Waller, GC., Kim, TG., Perez, S., et al.[2021]

The use of accelerometers to monitor physical activity in children after surgery is feasible, with 25 out of 60 enrolled patients successfully completing the study, providing objective data on recovery.

Recovery trajectories differ between inpatient and outpatient procedures, with outpatient patients returning to preoperative light physical activity levels by day 7 and moderate-to-vigorous activity peaking at 90% by day 8, while inpatient patients showed slower recovery rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using accelerometers to characterize recovery after surgery in children. Ghomrawi, HM., Baumann, LM., Kwon, S., et al.[2018]

In a study of 30 patients using Fitbit devices after head and neck surgery, those who took at least 200 steps on the first postoperative day had a significantly shorter hospital stay (4.5 days vs. 7.2 days).

The study found that wearable activity devices are effective for monitoring ambulation and sleep trends post-surgery, suggesting they could enhance recovery by providing valuable data on patient activity and sleep patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring postoperative ambulation and sleep after head and neck surgery: Feasibility and utility study using wearable devices. Pandrangi, VC., Jorizzo, M., Shah, S., et al.[2022]

Using consumer-based activity monitors (CAMs) during the perioperative period for patients undergoing major oncologic surgery is feasible, with 86% of participants providing analyzable data.

Despite high compliance before surgery, the significant drop in activity levels (77% reduction in daily steps) post-surgery suggests that CAMs could help identify patients at risk for postoperative complications, although traditional measures of functional status may not effectively capture these changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of low-cost accelerometers in measuring functional recovery after major oncologic surgery. Barkley, R., Khalil, M., Shen, P., et al.[2023]

The study tracked the recovery of 66 children who underwent the modified Nuss procedure using Fitbit step counts, revealing a steady increase in daily activity that plateaued around day 18 post-surgery.

This objective recovery trajectory can help set realistic expectations for patients and caregivers, potentially reducing unnecessary healthcare visits and improving post-discharge management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer Wearables Define a Normative Recovery Trajectory Following the Modified Nuss Procedure. Carter, M., Linton, S., Zeineddin, S., et al.[2023]

The study found that the Fitbit activity monitor showed moderate-to-good correlation with the SenseWear Armband, a reference standard accelerometer, for measuring steps and energy expenditure in 47 participants six months after total knee arthroplasty (TKA).

In contrast, the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire had poor-to-moderate correlation with the accelerometer, suggesting it may underestimate daily energy expenditures compared to more objective measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity of Tools to Measure Physical Activity in Older Adults Following Total Knee Arthroplasty. Jasper, L., Beaupre, LA., Spence, JC., et al.[2022]

The study involved nine participants with transfemoral amputations and used a Fitbit activity monitor to assess their mobility over one week, showing that activity levels correlated with their functional ability as classified by K levels.

The Fitbit activity score provided consistent insights into activity levels that were independent of individual factors like age, weight, and height, suggesting it could be a valuable tool for monitoring prosthetic use in everyday settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring daily function in persons with transfemoral amputations using a commercial activity monitor: a feasibility study. Albert, MV., Deeny, S., McCarthy, C., et al.[2014]

The study involved 26 children aged 3-18 who underwent appendectomy, using the FitBit Inspire HR to track their recovery over 21 days, revealing that those with simple appendicitis showed a faster recovery trajectory compared to those with complicated appendicitis.

Wearable technology like FitBit can effectively characterize postoperative recovery in children and differentiate recovery patterns based on the severity of the condition, potentially aiding in the early detection of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Wearable Sensors to Assess Postoperative Recovery in Pediatric Patients After Appendectomy. De Boer, C., Ghomrawi, H., Many, B., et al.[2021]

The Fitbit Flex activity monitor was found to be an invalid measure of step count and distance walked in post-cardiac surgery patients, based on a study involving 20 participants.

There was a significant discrepancy between the Fitbit outputs and manual measurements, indicating that the device should not be used as a clinical tool for monitoring walking progression in the early postoperative period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Fitbit Flex in an Acute Post-Cardiac Surgery Patient Population. Daligadu, J., Pollock, CL., Carlaw, K., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Continuous Digital Assessment for Weight Loss Surgery Patients. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Comparing Activity Trackers With vs. Without Alarms to Increase Postoperative Ambulation: A Randomized Control Trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Using accelerometers to characterize recovery after surgery in children. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Monitoring postoperative ambulation and sleep after head and neck surgery: Feasibility and utility study using wearable devices. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Feasibility of low-cost accelerometers in measuring functional recovery after major oncologic surgery. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Consumer Wearables Define a Normative Recovery Trajectory Following the Modified Nuss Procedure. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Validity of Tools to Measure Physical Activity in Older Adults Following Total Knee Arthroplasty. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Monitoring daily function in persons with transfemoral amputations using a commercial activity monitor: a feasibility study. [2014]

9. United States pubmed.ncbi.nlm.nih.gov

Utility of Wearable Sensors to Assess Postoperative Recovery in Pediatric Patients After Appendectomy. [2021]

10. Canada pubmed.ncbi.nlm.nih.gov

Validation of the Fitbit Flex in an Acute Post-Cardiac Surgery Patient Population. [2020]